The Avastin Travesty

Avastin is a cancer-fighting drug that works by starving tumors of vital nutrients and oxygen. Although Avastin doesn’t cure cancer, it can improve quality of life by slowing the disease’s spread. The Food and Drug Administration approved its use for colon cancer (2004), lung cancer (2006), and advanced breast cancer (2008).

But now the FDA is on the brink of rescinding that last approval, relegating breast cancer to the category of an “off-label” use. In our semi-socialized health care system, that’s significant because government-funded insurance plans (such as Medicare, Medicaid, and Tricare, which serves the military) refuse to reimburse off-label prescriptions, and private insurers generally follow their lead.

Since an Avastin breast cancer regimen costs as much as $88,000 annually, withdrawal of FDA approval would, in effect, lock the medicine cabinet and throw the key onto a high shelf, unreachable by many desperately sick patients.

The FDA is slated to decide whether to follow the advice of its own Oncologic Drugs Advisory Committee, which back in July voted 12-1 that Avastin does not “represent a favorable risk/benefit analysis.” Does that mean the drug fails to help any woman more than it hurts her? Not at all -- many individual women benefit from the drug. But the FDA regards such facts as sentimental distractions, to be deliberately ignored when deciding the fate of a drug like Avastin. The FDA’s idea of a risk/benefit analysis deals with health in the aggregate, as revealed in statistics involving large populations, not with the health of individuals.

But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer -- only individuals do. Metaphors aside, a society doesn’t get sick and die -- only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.

Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average -- or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?

The FDA’s experts take professional pride in refusing to allow such individual considerations to influence their decisions. Instead, they float among the statistical clouds, observing that Avastin delays tumor growth by only 3 to 12 weeks on average and that some patients actually get worse after taking the drug. From behind a veneer of scientific respectability supplied by charts and graphs that ignore the individual patient, these experts then ask a question to which no rational answer can be given: What is the meaning to society of one month in an individual’s life?

At this point, you may be sympathetic to these women’s plight and yet also concerned about the national economy. Won’t cancer patients spend us into bankruptcy with expensive drugs like Avastin? Well, that’s the kind of question that arises only when health care is collectivized by such programs as Medicare, Medicaid, and ObamaCare.

The antidote is to challenge the notion that health care is a right, to be funded by shoving everyone’s wealth into one big pot and spreading it among those in need. On a free market, in which health care is purchased by a combination of private insurance, savings, and charity, your neighbor’s decision to take an expensive drug like Avastin will be no more concern of yours than his choice to wear an expensive watch or drink an expensive wine.

This ongoing Avastin travesty pits a cancer-fighting drug against a drug-fighting cancer -- an out-of-control federal agency whose mission unashamedly includes choking off patients’ access to vital drugs. Reform should start by targeting the FDA’s power to substitute collectivized decisions for individual choice.